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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078527

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NDA 078527 describes FLUMAZENIL, which is a drug marketed by Hikma Farmaceutica, Claris, Fresenius Kabi Usa, West-ward Pharms Int, Sandoz Inc, Sagent Pharms, Teva Pharms Usa, and Mylan Labs Ltd, and is included in nine NDAs. It is available from fourteen suppliers. Additional details are available on the FLUMAZENIL profile page.

The generic ingredient in FLUMAZENIL is flumazenil. There are four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the flumazenil profile page.

Summary for NDA: 078527

Formulation / Manufacturing:see details

Pharmacology for NDA: 078527

Suppliers and Packaging for NDA: 078527

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 078527 ANDA West-Ward Pharmaceutical Corp 0143-9683 0143-9683-10 10 VIAL, MULTI-DOSE in 1 BOX (0143-9683-10) > 10 mL in 1 VIAL, MULTI-DOSE (0143-9683-01)
INJECTABLE;INJECTION 078527 ANDA West-Ward Pharmaceutical Corp 0143-9684 0143-9684-10 10 VIAL, MULTI-DOSE in 1 BOX (0143-9684-10) > 5 mL in 1 VIAL, MULTI-DOSE (0143-9684-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5MG/5ML (0.1MG/ML)
Approval Date:Mar 23, 2009TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:Mar 23, 2009TE:APRLD:No

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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
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US Department of Justice
Fish and Richardson

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